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The present project propose to study the effectiveness of a personalized care management of psycho-behavioral symptoms based on an evidence-based standardized assessment to identify and understand the underlying causes of psycho-behavioral symptoms followed by a personalized intervention based on targeted and prioritized actions. This personalized intervention is proposed both to Alzheimer disease (AD) patients living at home with agitation-type psycho-behavioral symptoms, and also to their caregivers with the support and coordination of a nurse working in collaboration with the specialist physician and the General Practitioner (GP). News technologies are used to enhance the follow-up, based on telehealth, and caregiver training.
The project hypothesize that, for a vulnerable population at risk (AD patient with agitation and their caregivers) living at home, a personalized intervention, carried out and coordinated by a nurse in close collaboration with the specialist and GP, would reduce hospitalizations and have a positive effect on the disease evolution and caregiver distress. Also this personalized intervention could reduce the cost of care, in particular by reducing the costs associated with hospitalizations and informal help.
PERSON-AL is a multicentric, interventional, open-label, randomized, parallel-group, stratified by centre, study comparing two arms: usual care versus intervention (personalized care preceded by a standardized assessment)
Principal Objective : To evaluate the impact of a personalized intervention for the management of agitation due to psycho-behavioral symptoms on the use of scheduled and unscheduled hospitalizations at 18 months in patients with AD and related disorders.
Secondary Objectives:
A- To evaluate the impact of a personalized intervention at 18 months on:
For the patient:
Unscheduled hospitalizations,
Severity of agitation symptoms,
The frequency and severity of emerging psycho-behavioral symptoms, other than agitation,
Prescription of psychotropic drugs,
Quality of life.
For the caregiver:
Distress related to psycho-behavioral symptoms,
All causes hospitalizations,
Quality of life.
B- Evaluate the medico-economic impact of this personalized intervention, and in particular:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (usual care) | No Intervention | Patients in the control group will benefit from the usual care with a half-yearly visit by the specialist physician (geriatrician, neurologist or psychiatrist) according to AD French national management guidelines (HAS 2011 and HAS 2018). | |
| Intervention (personalized care program) | Experimental | Patients in the intervention group will benefit from personalized care preceded by a standardized assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| personalized care preceded by a standardized assessment | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| patient's number of hospitalization at 18 months | number of all causes hospitalization, either scheduled or unscheduled, including emergency department visits | From the inclusion until End of Study, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| patient's unscheduled hospitalization | all causes hospitalization, unscheduled, including emergency department visits | From the inclusion until End of Study, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient agitation symptoms severity | assessed by Neuropsychiatric Inventory Clinician (NPI-C) scale based on the International Psychogeriatrics Association (IPA) (NPI-C-IPA) and Cohen-Mansfield Agitation Inventory (CMAI). | From the inclusion until End of Study, 18 months |
| severity and frequency of others emergent psycho-behavioral symptoms |
Inclusion Criteria:
For the patient :
For the caregiver:
Exclusion Criteria:
For the patient:
For the caregiver:
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| Name | Affiliation | Role |
|---|---|---|
| Maria SOTO, MD | University Hospital Toulouse - Gerontopole | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH d'Albi | Albi | France | ||||
| CH de Cahors |
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|
assessed by the NPI scale Frequency (0-4) Severity (0-3): Caregiver Distress (0-5): |
| From the inclusion until End of Study, 18 months |
| Number of psychotropic drug prescription for the patient | prescription checked at each visit | From the inclusion until End of Study, 18 months |
| patient's quality of life | assessed by the Euro Quality of life (EQ-5D-5L) scale | From the inclusion until End of Study, 18 months |
| Patient's psycho-behavioral symptoms distress on the caregiver | "distress" score of the Neuropsychiatric Inventory-Clinician rating scale-IPA scale Frequency (0-4) Severity (0-3): Caregiver Distress (0-5): | From the inclusion until End of Study, 18 months |
| caregiver's hospitalizations | all causes of hospitalization, either scheduled or unscheduled, including emergency department visits | From the inclusion until End of Study, 18 months |
| caregiver's quality of life | assessed by the Euro Qol (EQ-5D-5L) scale | From the inclusion until End of Study, 18 months |
| Cost/efficiency ratio and cost /utility differential from the community perspective | Cost/efficiency ratio and cost /utility differential from the community perspective | From the inclusion until End of Study, 18 months |
| Comparison between Standardized evaluation and personalized care program real cost | micro-costing approach of health costs | From the inclusion until End of Study, 18 months |
| quantity and cost health system resources used by the patient | health system resources used by the patient quantity and cost in comparison with efficiency and cost from the community perspective. | From the inclusion until End of Study, 18 months |
| efficiency and cost from the community perspective. | health system resources used by the patient quantity and cost in comparison with efficiency and cost from the community perspective. | From the inclusion until End of Study, 18 months |
| Cahors |
| France |
| Carcassonne Hospital | Carcassonne | 11000 | France |
| CHI Castres Mazamet | Castres | France |
| CH Lannemezan | Lannemezan | France |
| CH Lavaur | Lavaur | France |
| Limoges university hospital | Limoges | France |
| Lyon University Hospital | Lyon | France |
| CH Montauban | Montauban | France |
| Perpignan Hospital | Perpignan | France |
| CHI Val d'Ariège | Saint-Girons | France |
| Toulouse University Hospital (CHU de Toulouse) | Toulouse | 31059 | France |
| University Hospital Toulouse - Neurology department | Toulouse | 31059 | France |
| CH de Bigorre | Vic-en-Bigorre | France |
| HNO-Franche-sur-Soâne | Villefranche-sur-Saône | France |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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